Disposable, sterile fluid transfer device

ABSTRACT

The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

This application is a continuation of U.S. patent application Ser. No.11/350,384, filed Feb. 8, 2006, which is a divisional of U.S. patentapplication Ser. No. 10/500,077, filed Jun. 23, 2004, (now U.S. Pat. No.7,927,316, issued Apr. 19, 2011), which is a 371 of PCT/US2003/12927,filed on Apr. 25, 2003, which claims priority of U.S. ProvisionalApplication No. 60/375,747, filed on Apr. 26, 2002. The entire contentsare incorporated in their entirety herewith.

The present invention relates to a disposable, sterile fluid transferdevice. More particularly, it relates to a disposable sterile fluidtransfer device, preferably in the form of a connector or valve for usein the pharmaceutical and biopharmaceutical industry.

BACKGROUND OF THE INVENTION

In the pharmaceutical, biotechnology and even food, beverage andcosmetics industries, it is often desired to provide a processing systemthat is capable of handling fluids in a sterile manner. This is designedto prevent unwanted, often dangerous organisms, such as bacteria as wellas environmental contaminants, such as dust, dirt and the like fromentering into the process stream and/or end product. It would bedesirable to have a completely sealed system but this is not alwayspossible with the processes that take place in production.

There is a need for the introduction or removal of materials from theprocess stream in order to add components of the product, such as mediaor buffers to a bioreactor; withdraw samples from the process stream tocheck for microbial contamination, quality control, process control,etc; and to fill the product into its final container such as vials,syringes, sealed boxes, bottles and the like.

Typically, the systems have been made of stainless steel and the systemis exposed to live steam before use and then cleaned with chemicals suchas caustic solutions after use to ensure that all contaminants areremoved.

Steaming is the most effective means of sterilization. The use of steamin a set system is known as steaming in place or SIP. Saturated steamcarries 200 times the BTU heat transfer capacity of heated air becauseof the latent heat released by the steam as it changes from vapor toliquid.

Several disadvantages exist with the use of steam. Any connections to oropenings of the system made after the system has been SIP'd is anaseptic (but not sterile) connection or opening. This increases the riskof contamination of the entire system. One typically uses alcohol wipesor an open flame to clean the components to be connected, (e.g.connecting a sample collection bag to a system after SIP has occurred)and thus minimize the risk of contamination.

Also the high temperatures and pressure differentials of the steam makethe selection of filter materials and components very difficult andlimited and even then an accidental pressure differential at hightemperatures can cause a filter, membrane or other non-steel componentto fail.

Additionally, such systems that are reused need to undergo rigoroustesting and validation to prove to the necessary authorities that thesystem is sterile before each use. The expense of validation as well asthe cleaning regiment required is very high and very time consuming(typically taking 1 to 2 years for approval). In addition, somecomponents are very difficult to adequately clean after use inpreparation for their next use. Manufacturers are looking for ways toreduce both their costs and the time to market for their products. Onepossible approach is to adopt an all disposable system that is set up ina sterile fashion, used and then thrown away.

The present invention provides a connector that can be used in eitherthe traditional steel system or disposable system which provides both ameans for steam sterilizing the mating point of the connector to thesystem as well as providing a sterile downstream area or component, inpre-sterile condition, that can be disposed of after use and not berecleaned.

SUMMARY OF THE INVENTION

The present invention relates to a sterile transfer device for fluids,be they liquids or gases. It is comprised of a body having a bore formedthrough at least a portion of its interior. Preferably, it is a centralbore formed through the entire length of the body. Contained within thebore is a movable plunger. The body has a first and a second end. Thefirst end contains a face designed to be attached to the upstreamcomponent. The second end is connected to a downstream component such asa filter, pipeline, sample bag and the like. The plunger hascorresponding first and second ends. The first end of the plunger whenit the closed position is in alignment with the face of the body whichcombined form a steamable surface and a sterile barrier against theenvironment to the rest of the interior of the body, the plunger anddownstream components.

The downstream components are assembled to the device and it is placedin the closed position. The entire device and downstream components aresterilized, such as with gamma radiation. In use the device anddownstream components are attached by the face to the upstream componentsuch as a filter outlet, a tank outlet, a “T” of a pipe and secured inplace. The system and the face of the device are then steam sterilizedin place. The device is then selectively opened when needed establishinga sterile pathway through the device to the downstream components.

IN THE DRAWINGS

FIG. 1 shows a cross sectional view of a first embodiment of the presentinvention in a closed position.

FIG. 2 shows a cross sectional view of the first embodiment of thepresent invention of FIG. 1 in an open position.

FIG. 3 shows a cross sectional view of the first embodiment of thepresent invention of FIG. 1 mounted to an upstream component.

FIG. 4 shows a cross sectional view of a second embodiment of thepresent invention in a closed position.

FIG. 5 shows a cross sectional view of a second embodiment of thepresent invention of FIG. 3 in an open position.

FIG. 6 shows a cross sectional view of another embodiment of the presentinvention.

FIG. 7 shows a cross sectional view of another embodiment of the presentinvention.

FIG. 8 shows a cross sectional view of another embodiment of the presentinvention.

FIG. 9A shows a perspective view of a locking mechanism of the presentinvention in unopened condition.

FIG. 9B shows a perspective view of the locking mechanism of 9A of thepresent invention in the opened condition.

FIG. 9C shows a perspective view of the locking mechanism of 9A of thepresent invention in the reclosed position.

FIG. 10A shows a perspective view of a locking mechanism of the presentinvention in unopened condition.

FIG. 10B shows a perspective view of the locking mechanism of 10A of thepresent invention in the opened condition.

FIG. 10C shows a perspective view of the locking mechanism of 10A of thepresent invention in the reclosed position.

FIG. 11A shows a perspective view of a locking mechanism of the presentinvention in unopened condition.

FIG. 11B shows a perspective view of the locking mechanism of 11A of thepresent invention in the opened condition.

FIG. 12A shows a perspective view of a locking mechanism of the presentinvention in unopened condition.

FIG. 12B shows a perspective view of the locking mechanism of 12A of thepresent invention in the opened condition.

FIG. 12C shows a perspective view of the locking mechanism of 12A of thepresent invention in the reclosed position.

FIG. 13 shows a perspective view of a locking mechanism of the presentinvention in unopened condition.

FIG. 14 shows an alternative design of the present invention.

FIG. 15 shows another embodiment of the device of the present invention.

FIGS. 16A-I show other embodiments of the device of the presentinvention in cross sectional view.

FIG. 17 shows the device of the present invention in one potentialapplication in which there is a sterile to nonsterile connection.

FIG. 18 shows the device of the present invention in one potentialapplication in which there is a sterile to sterile connection.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a sterile fluid transfer device, preferably inthe form of a connector or a valve.

A first embodiment of the present invention is shown in FIG. 1. Thedevice 2 is formed of a body 4 having a first end 6 and a second end 8.The body 4 also has a bore 10 extending in this embodiment from thefirst end 6 to the second end 8. The bore 10 as shown is formed of threesections each with a different diameter. There is the first bore section12 which has a first set diameter, a transition bore section and asecond bore section which has a second set diameter that is greater thanthe first set diameter of the first bore section 12. The transition boresection 14 is arranged between the first and second bore sections 12, 16and has an outwardly tapering diameter along its length with thediameter of the transition section 14 adjacent the first bore section 12being equal to the first set diameter and the diameter of the transitionsection 14 adjacent the second bore section 16 being equal to the secondset diameter. The diameter of the transition section between the firstand second bore sections is preferably a linear outward progressionbetween the two bore sections.

Contained within the bore is a plunger 18 which has a shapecorresponding to that of the bore 14. The plunger has a first portion 20having a diameter equal to or less than that of the diameter of thefirst bore section, a second plunger portion 22 having a diameter equalto or less than that of the second bore section and a transitionalportion 24 between the first and the second plunger portions 20, 22having an outwardly tapered diameter between the first and secondplunger portions 20, 22 equal to or less than the diameter of thetransition bore section 14. The plunger 18 also contains one or moreopenings 26 in either the transitional portion 24 or the first or secondportions 20, 22 as well as a fluid channel 27 that forms a fluidconnection to a downstream component or tubing (not shown).

As shown, the farthest part 28 of the second portion 22 contains a barbdesign 30 to connect to the next downstream component. The plunger alsocontains several preferable elements that are useful but not necessaryto the invention. Included among these are a cam 32 and a connectorhandle 34. The cam 32 rides in a cam slot 36 formed in the body 4 andtogether is used to limit the length of travel of the plunger 18 in thebore 14.

The device is shown in FIG. 1 in the closed position. One or more seals38 are arranged along the length of the plunger 18 to form a liquidtight seal between various portions of the plunger 18 and the bore 14when they are in the closed or open positions. As shown the seals 38 arecontained in grooves 40.

The device 2 is attached to an upstream component or pipe by a sanitaryflange 42 formed as part of the body 4. In the closed position theflange 42 and the farthestmost end of the first portion of the plunger44 form a face 46 against the rest of the system. The flange 42 can beattached to the upstream component or pipe by a clamp such as aTri-Clover™ fitting, Ladish™ fitting, ClickClamp™ clamp or the like.This face 46 is capable of withstanding steam treatment when in thedevice is in the closed position as will be described in more detailbelow.

FIG. 2 shows the device 2 of FIG. 1 in the open position. To the extentthat the same reference numbers apply to both FIGS. 1 and 2 they havebeen kept the same.

In FIG. 2, the plunger has been moved from the closed position of FIG. 1to an open position. The farthestmost end of the first portion of theplunger 44 has been moved back from the face 46 providing a passageway48 to the bore 14 and the one or more openings 24 and the fluid channel26 forming a fluid connection between the upstream 50 and downstreamsides 52 of the device 2. As shown, the plunger is moved rearward ordownstream and rotated at the same time, as evidenced by the movement ofthe cams 32 in the cam slot 36.

FIG. 3 shows the device 2 of FIG. 1 mounted to an upstream component 54,in this instance a “T” pipe and a downstream component 56, in thisinstance a piece of hose or plastic pipe. Also shown is liquid tightseal 58 formed between the flange of the device 2 and a flange 60 (clampnot shown).

FIGS. 4 and 5 show an embodiment of the present device 61 in which thereis no fluid passage formed in the plunger. Instead, the body contains aport 62 which provides the fluid connection to the downstream component64, in this instance a piece of plastic piping. As shown in the closedposition, the farthestmost end 66 of the first portion 68 of the plunger70 seals off the downstream side of the device 61 from the upstreamcomponent 72. The port 62 is shown as being at a 90 degree angle to thelength of the body, but it may be any other desired angle.

As shown in FIG. 5, when the device of FIG. 4 is opened, thefarthestmost end 66 of the first portion 68 of the plunger 70 has beenmoved back from the face 72 providing a passageway 74 to the bore 76 andthe port 62 so as to provide fluid communication between the upstreamcomponent 72 and the downstream component 64 through the device 61.

As shown in FIGS. 1-5, the seals may be mounted on the plunger of thedevice. Further, the seals shown in FIGS. 1-5 are O-rings, eitherpre-formed and retained within grooves on the plunger or formed in placein the grooves of the plunger. However, if desired, differentconfigurations of seals and their placements can be used. For example,FIG. 6 shows some seals 80 formed on the plunger 82 with other seals 84held in grooves 86 in the inner surface of the bore 88.

FIG. 7 shows an embodiment with a linear or gland seal 90 is retainedwithin a groove 92 on the inner wall of the body 94 and other seals 96attached to the plunger 98 in grooves 100.

FIG. 8 shows a similar design to that of FIG. 7 except that the glandseal 90 is formed on the outer wall 91 of the plunger 98 and other seals96 are attached to the plunger 98 in grooves 100.

As this is device is provided in a sterile condition, i.e. the interiorof the system and any component connected downstream of the device ispre-sterilized such as with gamma radiation, ethylene gas or the likeand shipped in a sterile condition, some type of use indicator would behelpful so one knows when a system has been used and should therefore bereplaced.

FIG. 9A shows a first embodiment of an indicator useful on the presentinvention. As shown in the FIG. 9A, the body section 102 distal from thesteamable face 104 has a series of one or indentations or lockingrecesses or fixed pawls 106. The plunger 108 has a mating detent 110which is located in one of the recesses before the device is sterilized.The device is shipped in this sterile condition with the detentremaining in the recess. In fact, the detent/recess combination works toensure that the device doesn't accidentally open due to vibration orhandling during shipping.

The device is then taken from its sterile container in the closedposition of 9A and attached by its face to the system. The face is thensteam sterilized. The device is then opened by rotating the handle to anopen position as shown in FIG. 9B.

When the device is closed after use, the handle 112 of the plunger 108is capable of moving the detent 110 past the first recess and into thesecond recess 106 as shown in FIG. 9C. This provides a visual indicationto the user that the device is no longer sterile. In addition, itprovides a manual indication to the user that the device has been usedas the detent 110 has to be turned past the two recesses 106, each withan affirmative clicking action before the device can be opened.Moreover, one can design the walls of the farthermost (used condition)recess 106 so that the movement out of the recess requires anextraordinary amount of force to again indicate to the user that thedevice has been used and shouldn't be reused.

FIG. 10A shows another embodiment of an indicator useful on the presentinvention. As shown in the FIG. 10A, the body section 113 distal? fromthe steamable face (not shown) has a series of one or indentations orlocking recesses or fixed pawls 106 as well as one or more breakawaytabs 114. The plunger 108 has a mating detent 110 which is located inone of the recesses 106 before the device is sterilized as well as abreaking bar 116. The device is shipped in this sterile condition withthe detent remaining in the recess and the breaking bar being positionedbehind the breakaway tab.

The device is then taken from its sterile container in the closedposition of 10A and attached by its face (not shown) to the system. Theface is then steam sterilized. The device is then opened by rotating thehandle 112 to an open position as shown in FIG. 10B. In doing so thebreaking bar 116 rotates past and over the breakaway tab 114, causing itto be bent over or removed altogether.

When the device is closed after use, the handle 112 is capable of movingthe detent 110 past the first recess 106 and into the second recess 106Aas shown in FIG. 10C.

FIGS. 11A and B show a plastic feature extending from the body thatforms another breakaway (or bend-away) indicator. FIG. 11A, shows thevalve in its shipped (or pre-sterilized) position. It is intended thatwhen the valve is opened, this protruding feature will break away or atleast bend away from its original position, thereby indicating that thevalve has been actuated and should not be used again once it has beensubsequently closed. FIG. 11B shows the valve in the open position,showing the tab feature as being bent.

FIG. 12A shows another embodiment of an indicator useful on the presentinvention. As shown in the FIG. 12A, the body section 113 distal fromthe steamable face (not shown) has a series of one or indentations orlocking recesses or fixed pawls 106 as well as one or more tab retainers120. The plunger 108 has a mating detent 110 which is located in one ofthe recesses 106 before the device is sterilized as well as a breakawayor fold over tab 122. The device is shipped in this sterile conditionwith the detent remaining in the recess and the breaking bar beingpositioned behind the breakaway tab.

The device is then taken from its sterile container in the closedposition of 12A and attached by its face (not shown) to the system. Theface is then steam sterilized. The device is then opened by rotating thehandle 112 to an open position as shown in FIG. 12B. In doing so the tab122 in tab retainer 120 rotates out of the retainer 120, causing it tobe bent over or removed altogether.

When the device is closed after use, the handle 112 is capable of movingthe detent 110 past the first recess 106 and into the second recess 106Aas shown in FIG. 12C with the tab 122 if it remains being bent up andnot being returning to the retainer 120.

As an alternative or in addition to any of the mechanisms discussedabove, as shown in FIG. 13 one may use a shrink wrap indicator 130 overthe device or at least the handle portion 132 of the plunger 134 and thesurrounding body 136 of the device to indicate that the device is in anunopened condition.

As an alternative to the face of the device as shown in FIG. 1, one mayuse a foil 160, metal or plastic, such as PEI, PEEK, polysulphones,aluminum, stainless steel and the like, adhered to the body portion 162of the face 164 and used to form the sterile seal as shown in FIG. 14.It is then pierced or penetrated by the plunger 166 to establish a fluidflow. A rubber septum in lieu of the foil could also be used. A scoredsurface can also be used. The foil may be adhered in a variety ofmanners that are well known in the art such as heat sealing, vibrationwelding such as ultrasonic welding, solvent bonding and through the useof adhesives such as epoxies and urethanes.

FIG. 15 shows another embodiment of the present invention. In thisembodiment the body of the device is formed as an integral component ofa pipe. Preferably the pipe is made of a steam resistant plastic(described below) or alternatively, it may be made of a metal such asstainless steel so long as it contains the necessary features of thepresent invention. The body can be formed as an arm of the piece asshown. The plunger (as shown being similar to that of FIG. 1) is theninserted into the body of the piece.

FIGS. 16A-I show several other connectors devices that fall within thepresent invention. FIG. 16A is similar to the valve design of FIG. 14A.It is comprised of a body 180, and a plunger 181 contained with in abore 182 of the housing. The plunger has a fluid channel 185 connectingit in fluid communication to the rest of the downstream side of thedevice and beyond. A face 183 is formed by the outermost portion of thebody 180 and plunger 181. Unlike the embodiment of FIG. 1, the bore 182is essentially linear as is the plunger 181. As shown, the device is inits open position. The plunger 181 rather than retracting into the bore182, is extended out from the bore to expose an opening or openings 184so as to create fluid communication between one en d and the other endof the device.

FIG. 16B shows a close up variant of the design of FIG. 16A. In thisvariant, the opening 184B is formed at a right angle to the fluidchannel 185B only on one side of the plunger.

FIGS. 16C and D show a close up cross-sectional view of anotherembodiment. In this variant, the upstreammost portion of the plunger181C is in the form of series of spring fingers 186. The plunger 181C ispulled back into the bore 182C to open the device as shown in FIG. 16D.Fluid then flows into the bore 182C, into openings 184C through thefluid channel 185C to the downstream component.

FIGS. 16E and F show a close up cross-sectional view of anotherembodiment. In this variant, the upstreammost portion of the plunger 181E is in the form of compression nut 187. The plunger 181E is pulled backinto the bore 182E to open the device as shown in FIG. 16F. Fluid thenflows into the bore 182E, into openings 184E through the fluid channel185E to the downstream component.

FIG. 16G shows another embodiment of the present invention. In thisdesign, the plunger 181G is actually mounted to move laterally withinthe bore 182G of the housing 180G in a push/pull fashion to open andclose the device. The face 183G is formed of the upstream end of thebody and the plunger 181G as shown.

FIG. 16H shows a rotatable device with the body 180H being formed of twopieces 188A and 188B. The plunger 181H is contained within a portion ofthe bore 182H as shown. The plunger as shown is in the closed position.The face 183H is formed by the upstreammost portions of the plunger 182Hand the body portion 188B. Also as shown the upstream component isattached to the plunger 181H. As the plunger is rotated from its closedto its open position, the fluid channel 185H of the plunger aligns witha fluid channel 189 of body portion 188B to establish fluidcommunication through the device.

FIG. 16I shows another variant of the rotational design. Here thePlunger 181I is retained in the bore 182I of the body 180I by a groove190 and abutment 191. When the plunger 181I is rotated to its openposition, fluid may pass through the bore 182I into the fluid channel185I through opening 184I.

FIG. 17 shows the device of the present invention in one potentialapplication in which there is a sterile to nonsterile connection. Asshown the fluid transfer device 200 of the embodiment shown in FIG. 3 isattached by its face (not shown) to a connection point 204 such as a “T”fitting on a process pipe 206 as shown. A clamp 202 holds the adjoiningand mating faces (not shown, but see FIG. 3 for details of the matingassembly) of the device and the pipe 206 together in a liquid tightarrangement. The exit of the device 208 here in the form of a barb isconnected to a tube 210 which in turn is connected to a collection bag212. In use, the device 200 is in a closed position and has the tube 210and bag 212 connected to it. The device with the tube and bag are thengamma sterilized (i.e. by gamma irradiation) or otherwise sterilized.

The device with the tube and bag is then attached to the pipe by thedevice face (not shown) by the clamp 202. The face is then steamsterilized along with the remainder of the system and is ready for use.When it is desired to fill the bag 212, one simply opens the device 200by rotating the handle 214 which moves the plunger (not shown) away fromthe face creating an opening into the bore for the fluid to flow out theexit 208 through tube 210 and into the bag 212. Once the bag 212 isfull, the handle is rotated the opposite direction to close the bore tothe fluid. The bag 212 can then be closed off via a clamp or hemostat(not shown) and removed for further processing or use.

FIG. 18 shows a system using the device of the present invention whereintwo sterile devices can be connected together. As shown, one can use aconnector 300 formed of four interconnecting arms 302 A, B, C and D theend of each arm 302 A, B, C and D having a mating flange 304 A, B, C andD. a first sterile transfer device 306 of the present invention inattached to arm 302A and a second device 308 is attached to a second arm302B. A live steam line 310 is attached to arm 302C and asteam/condensate trap 312 is attached to arm 302D. Alternatively, onecould attach a sterile barrier filter as taught by PCT/US01/47425, filedDec. 3, 2001 and available from Millipore Corporation of Bedford, Mass.to arm 302D to remove the condensate after steaming.

Devices 306 and 308 are attached to other components of the system (notshown) and as with the embodiment of FIG. 14 are presterilized such aswith gamma radiation before assembly the connector 300.

After assembly, steam enters through line 310 to sterilize the entireinterior of connector 300 and the steamable faces of the devices 306 and308. The steam then shut off and the steam/condensate is removed to thetrap 312 which is then shut off from the connector 300. Devices 306 and308 are then opened to form a sterile to sterile connection betweenthem.

Other uses will be found for these devices. For example, they can beused to isolate a steam fragile component, such as some filters withsteam sensitive membranes, in a process line. The filter especially inthe form of a disposable capsule can be attached to the device andpresterilized (such as by gamma). The device can then be connected tothe line which is then steam sterilized and the device is then opened toprovide fluid flow to the filter. If desired the inlet and outlet of thefilter can contain such devices the outermost ends of which have thesteam sterilizable face. Alternatively, a device can be attached to eachend of a length of tube to form a sterile transfer pipe. Other uses canalso be made of the present invention. Additionally, the connector ofthe present invention can be connected or actually molded into adisposable plastic container such as disposable process bag for themanufacture and transfer of biotech products. Such bags are readilyavailable from companies such as Hyclone of Utah and Stedim of France.

The device is formed a plastic material and may be formed by machiningthe body and plunger assemblies and then applying the necessary sealsand the like, or preferably by molding the body and the plungerseparately and assembling them together with the necessary seals andother components.

The device may be made of any plastic material capable of withstandingin line steam sterilization. The temperature and pressure of suchsterilization is typically about 121.degree. C. and bar aboveatmospheric pressure. In some instances, it may be desirable to use evenharsher conditions such as 142.degree. C. and up to 3 bar aboveatmospheric pressure. The body and at least the face of the plungershould be capable of withstanding these conditions. Preferably, theentire device is made of the same material and is capable ofwithstanding these conditions. Suitable materials for this deviceinclude but are not limited to PEI (polyetherimide), PEEK, PEK,polysulphones, polyarlysulphones, polyalkoxysulphones,polyethersulphones, polyphenyleneoxide, polyphenylenesulphide and blendsthereof. Alternatively, one can make the face portion from ceramic ormetal inserts alone or that are overmolded with a plastic cover One canalso form a polymeric face with a metal outer layer using plasma coatingprocesses.

The seals of the present invention can be made of a variety of materialstypically used for making resilient seals. These materials include butare not limited to natural rubber, synthetic rubbers, such as siliconerubbers, including room temperature vulcanizable silicone rubbers,catalyzed (such as by platinum catalysts) silicone rubbers and the like,thermoplastic elastomers such as SANTOPRENE® elastomers, polyolefinssuch as polyethylene or polypropylene, especially those containing gasbubbles introduced either by a blowing agent or entrained gas such ascarbon dioxide, PTFE resin, thermoplastic perfluoropolymer resins suchas PFA and MFA resins available from Ausimont, USA of Thorofare, N.J.and E.I. DuPont de Nemours of Wilmington, Del., urethanes, especiallyclosed cell foam urethanes, KYNAR® PVDF resin, VITON®) elastomer, EPDMrubber, KALREZ resin and blends of the above.

Suitable materials for molded in place seals can be curable rubbers,such as room temperature vulcanizable silicone rubbers, thermoplasticelastomers such as SANTOPRENE® elastomers, polyolefins such aspolyethylene or polypropylene, especially those containing gas bubblesintroduced either by a blowing agent or entrained gas such as carbondioxide and elastomeric fluoropolymers.

Other materials used in the devices should also be FDA grade componentssuch as FDA grade silicones, PTFE resins and the like.

The present invention provides a sterile and steam sterilizableconnecting device for fluid transfer. It may be single actuation (oneopen one close) or it may be multiple actuations with a single sterileconnection (multiple openings and closings so long as the sterileconnection upstream and downstream is maintained). Additionally, withthe use of multiple seals or seals of long length, one is able to ensurethat the sterility of the device is maintained even with multipleactuations.

What is claimed is:
 1. A sterile fluid transfer device, comprising: abody having a bore formed through at least a portion of its interior,the body having a first end having a flange attachable to an upstreamcomponent; a port positioned downstream from the first end of the body,the port being connectable to a downstream component; a plungercontained within the bore, the plunger having a first end and beingmovable within the bore between a closed position in which the device isclosed and the first end of the body is sealed off from the port and anopen position in which the device is open and the first end of the bodyand the port are fluidly connected; a fluid pathway forming a fluidconnection through the device between the first end of the body and theport when the device is open; and a sterile barrier between theenvironment and at least a portion of the interior of the body to enablethe transfer of fluid through the fluid pathway while maintaining thesterile condition of the fluid being transferred so long as a sterileconnection to the upstream component and the downstream component ismaintained, the sterile barrier comprising one or more seals arrangedalong the length of the plunger to form a liquid tight seal between theplunger and the bore when the plunger is in the open position, whereinthe one or more seals is an O-ring seal, a gland seal or a combinationthereof.
 2. The device of claim 1, wherein the sterile barrier comprisestwo seals arranged along the length of the plunger to form a liquidtight seal between portions of the plunger and the bore when the plungeris in the open position.
 3. The device of claim 1, wherein the sterilebarrier comprises a gland seal arranged along the length of the plungerto form a liquid tight seal between portions of the plunger and the borewhen the plunger is in the open position.
 4. The device of claim 1,wherein the plunger is movable from the closed position to the openposition by axial movement and rotation.
 5. The device of claim 1,further comprising a handle formed on the plunger to move the plungerwithin the bore between the closed position and the open position. 6.The device of claim 1, further comprising a cam slot formed in the bodyand a cam formed on an outer surface of the plunger and contained withinthe cam slot, wherein the cam remains within the cam slot as the plungermoves within the bore between the closed position and the open position.7. The device of claim 1, further comprising a cam slot formed in thebody, a cam formed on an outer surface of the plunger and containedwithin the cam slot, and a handle formed on the plunger to move theplunger within the bore between the closed position and the openposition, wherein the cam remains within the cam slot as the plungermoves between the closed position and the open position.
 8. The deviceof claim 1, wherein the sterile barrier comprises three O-ring seals. 9.The device of claim 1, wherein the sterile barrier comprises a glandseal.
 10. The device of claim 1, wherein the device maintains thesterile condition of the fluid being transferred through a singleactuation of the device.
 11. The device of claim 1, wherein the devicemaintains the sterile condition of the fluid being transferred throughmultiple actuations of the device.
 12. The device of claim 1, whereinthe device is made of a plastic material.
 13. The device of claim 1,wherein the port is on the plunger downstream of the first end of thebody, and the plunger further includes one or more openings fluidlyconnected to the port.
 14. The device of claim 1, wherein at least oneof the one or more seals is configured to allow the first end of thebody and the port to be fluidly connected when the plunger is in theopen position and seals off the first end of the body from the port whenthe plunger is in the closed position.
 15. A disposable system,comprising a sterile fluid transfer device of claim 1 and an upstreamcomponent attached to the flange of the sterile fluid transfer device.16. The disposable system of claim 15, further comprising a downstreamcomponent connected to the port of the sterile fluid transfer device.17. A sterile fluid transfer device, comprising: a body having a boreformed through at least a portion of its interior, the body having afirst end having a flange attachable to an upstream component; a portpositioned downstream from the first end of the body, the port beingconnectable to a downstream component; a plunger contained within thebore, the plunger having a first end and being movable within the borebetween a closed position in which the device is closed and the firstend of the body is sealed off from the port and an open position inwhich the device is open and the first end of the body and the port arefluidly connected; a fluid pathway forming a fluid connection throughthe device between the first end of the body and the port when thedevice is open; and a sterile barrier between the environment and atleast a portion of the interior of the body to enable the transfer offluid through the fluid pathway while maintaining the sterile conditionof the fluid being transferred so long as a sterile connection to theupstream component and the downstream component is maintained, thesterile barrier comprising: two seals arranged along the length of theplunger to form a liquid tight seal between portions of the plunger andthe bore when the plunger is in the open position; or a linear or glandseal arranged along the length of the plunger to form a liquid tightseal between portions of the plunger and the bore when the plunger is inthe open position.
 18. A disposable system, comprising a sterile fluidtransfer device of claim 17 and an upstream component attached to theflange of the sterile fluid transfer device.
 19. The disposable systemof claim 18, further comprising a downstream component connected to theport of the sterile fluid transfer device.